Targeted phage therapy for recurrent urinary infections in women with kidney transplants.

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

Researchers will run a randomized, placebo-controlled Phase 1/2 pilot trial comparing targeted bacteriophage therapy to saline placebo in asymptomatic adult female kidney transplant recipients with a history of recurrent E. coli urinary tract infections. Thirty-two participants will be randomized 1:1 and followed for 180 days to measure safety, tolerability, feasibility, and preliminary effects on UTI event rate and the gut and urinary microbiome. The phage will be given without concurrent antibiotics and both participants and staff will be blinded using identical clear 1 mL syringes. Results will provide proof-of-concept data to inform the design of a larger Phase 3 trial if the approach appears safe and promising.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Female kidney transplant recipients, aged 18 and older with a confirmed diagnosis of a history of recurring UTI with E. coli as their typical uropathogen.
2. Two urine culture proven UTIs in prior 6 months or three in prior 12 months due to E coli. UTI is defined as any change in symptoms from baseline urinary comfort (dysuria, hematuria, abdominal/flank pain, increased urinary frequency) or systemic signs of infection (fever, chills, systemic inflammatory reaction syndrome etc.) associated with a positive urine culture with bacterial growth of ≥104 colony forming units/mL).
3. Ability to self-administer study drug (or a family member that will do so) and willing to adhere to the phage therapy regimen.
4. For participants able to become pregnant: use of highly effective contraception for at least 1 month prior to screening and agreement to use such a method during study participation and for an additional 6 months after the end of phage therapy administration.
5. Provision of signed and dated informed consent form
6. Stated willingness to comply with all study procedures and availability for the duration of the study.

Exclusion Criteria:

1. Presents with hardware in the urinary tract (e.g. stent, percutaneous nephrostomy, chronic urinary catheter).
2. Recipient of \>1 kidney transplant.
3. Recipient of Ileal conduit.
4. Recipient of surgical neobladder.
5. Diagnosed with chronic urinary retention requiring self-catheterization.
6. Anatomic cause for rUTI such as ureteral stenosis.
7. Within the first 3 months of kidney transplant.
8. Venous access sites or in whom an existing venous access site needs to be preserved for future need (as per the participant's transplant nephrologist/ surgeon)
9. Diagnosed with active cytomegalovirus or BK virus infections.
10. Current pregnancy, actively trying to conceive, or lactating.
11. Known allergic reactions to phage products.
12. Prisoners or individuals without decisional capacity.

Where it's running

• University of California, San Diego
  La Jolla, California, United States Recruiting

Study contacts

• Study coordinator: Saima Aslam, M.D.
• Email: rUTIphagestudy@health.ucsd.edu
• Phone: (619) 543-3108

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.